FDA Product Code FBK: Endoscopic Injection Needle, Gastroenterology-urology
Endoscopic injection enables precise delivery of agents to gastrointestinal lesions. FDA product code FBK covers endoscopic injection needles for gastrointestinal use.
These retractable needle devices are passed through the working channel of an endoscope to inject hemostatic agents, sclerosants, submucosal lifting solutions, and chemotherapeutic agents directly at target sites within the gastrointestinal tract.
FBK devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Ningbo Xinwell Medical Technology Co., Ltd., Steris and Promisemed Hangzhou Meditech Co., Ltd..
FDA 510(k) Cleared Endoscopic Injection Needle, Gastroenterology-urology Devices (Product Code FBK)
About Product Code FBK - Regulatory Context
510(k) Submission Activity
87 total 510(k) submissions under product code FBK since 1981, with 87 receiving FDA clearance (average review time: 119 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under FBK have taken an average of 162 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.
FBK devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →